Emily Henderson and a record breaking drug trial

An inspirational doctor makes a difference

I am both fascinated and frustrated by clinical trials for new drugs - fascinated because they offer the hope of new treatments, frustrated because they seem to be burdened with huge amounts of bureaucracy and take an awfully long time. But in trying to find out a bit more about how trials work I’ve come across an inspirational doctor who is showing that with sheer determination you can hurry things up.

Dr Emily Henderson, a geriatrician specialising in Parkinson’s, is the Chief Investigator for the phase 3 CHIEF-PD trial. This is looking at whether drugs normally used to treat people with memory problems can be used to reduce the number of falls that people with Parkinson’s experience.

Getting hold of a slot in Dr Henderson’s calendar for a chat proved tricky - mostly because of my incompetence - but when I finally got her on the phone I realised that she must be the world’s busiest person. It was when she revealed that she had carried out the phase 2 CHIEF trial of the Alzheimer’s drug rivastigmine as part of her PhD that this realisation dawned. “Is that….normal?” I stuttered.

“It’s almost unheard of for people to do drug trials independently as a PhD,” she admitted. She recruited 130 participants in six months, tested them face to face, followed up with monthly phone calls to find out how many falls they had had, and saw them again at the end of the trial, operating from a caravan in a hospital car park.

“Yes, it was a really extraordinary undertaking,” she says. “I don’t know - if I could go back and do it all again - whether I'd ever consider at this juncture whether it was a good idea.” But the results were exciting - a 45% reduction in falls for the people taking the drug.

While the big headlines in Parkinson’s research are understandably about drugs like Exenatide or Ambroxol which might slow or halt the progression of the disease, a medication that could cut falls would be hugely valuable. A recent survey showed that falls and balance problems were the number one research priority for people living with Parkinson’s.

Dr Henderson says there are good reasons for that: “It's one of the most disabling and potentially devastating consequences of the disease because it leads to injuries and hospitalisation and loss of independence.”

After that phase 2 trial, the National Institute of Health provided her with over £2 million to move to phase 3, the final step in the process of proving rivastigmine works. This is a much bigger undertaking and cannot be a solo effort, but Emily Henderson has now mobilised a team at Bristol Medical School’s Ageing and Movement Research Group to run the trial.

This involves recruiting 600 people for a double blind randomised trial where they will wear patches, half containing the drug, half a placebo. It’s a huge undertaking, the biggest Parkinson’s trial ever undertaken in the UK, with 39 NHS centres across the country helping to assess participants. The hunt is on for people with Parkinson’s who have had a fall in the past year and can walk at least 10 metres - and it is going very well. Just 32 more patients are needed - you can find out more here.

So how long, I ask, before the trial is complete and, if successful, the drug can be prescribed? I am expecting to hear that it will be many years - probably the end of this decade - before there is a chance of “Parkies” being prescribed rivastigmine to stop them falling over.

Instead, Dr Henderson said she hoped to get preliminary results from the trial by late 2024 and if they were positive then NICE (National Institute for Clinical Excellence) approval to prescribe the drug could follow quickly. (As rivastigmine is already approved for treating dementia in Parkinson’s, there is the likelihood that GPs will start prescribing it for a wider range of patients in any case.)

What is so inspiring about Emily Henderson is her optimism and her can-do attitude to drug trials. “It'd be great if we were to reproduce the findings (of the phase 2 trial)”, she tells me. “It would be really groundbreaking both for Parkinson's and potentially other neurodegenerative diseases.”

I wrote recently that a breakthrough in Parkinson’s treatment always seems to be five years away. Well, the CHIEF-PD trial won’t lead to a cure but two years from now it could bring a substantial improvement to the lives of people living with this condition. One listener to the Movers and Shakers podcast wrote that we all needed a dose of the drug “hopeamine” from time to time. That’s exactly what Emily Henderson and her team are giving me right now.